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Safety and Efficacy of Ultra-Rush Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen

This study has been completed.
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00518518
First received: August 17, 2007
Last updated: May 14, 2009
Last verified: May 2009
History of Changes
  Purpose

The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. The investigators will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of sublingual immunotherapy (SLIT) in children with asthma.


Condition Intervention Phase
Asthma
 Drug: Staloral 300
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Ultra-Rush High-Dose Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen - Prospective, Randomized, Placebo Controlled Study.

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • clinical symptoms, reliever drugs usage, controller medication usage, lung function [ Time Frame: all visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • chosen markers of inflammation (specific IgE, IgG4, eosinophils) [ Time Frame: 1 month after baseline visit (second visit), after 5 months (fifth visit), after 18 months (ninth visit), after 30 months (thirteenth visit) ] [ Designated as safety issue: No ]
  • skin prick test, specific nasal provocation test with grass pollen allergen [ Time Frame: baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit) ] [ Designated as safety issue: No ]
  • bronchial hyperreactivity with methacholine [ Time Frame: after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit) ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Staloral 300
Staloral 300
Other Name: Staloral 300
Placebo Comparator: 2 Drug: placebo
placebo
Other Name: placebo

Detailed Description:

Specific immunotherapy is the only causal treatment method of atopic diseases including bronchial asthma in children. Sublingual immunotherapy seems to be the most promising alternative to traditional specific subcutaneous injection immunotherapy.

The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. We will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SLIT in children with asthma.

After two years the study will be unblinded, all the children will be given grass pollen allergen extract for a year.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients allergic to grasses pollen
  • patients with bronchial asthma
  • patients with controlled asthma
  • patients who were qualified for immunotherapy and gave written informed consent for immunotherapy

Exclusion Criteria:

  • patients allergic for other perennial and seasonal allergens
  • patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518518

Locations
Poland
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Lodz, Poland, 93-513
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Joanna Kaczmarek, MD Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair: Iwona Stelmach, MD, PhD, Prof Department of Pediatrics and Allergy, Medical University of Lodz, Poland
  More Information

Publications:

Responsible Party: Iwona Stelmach MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland.
ClinicalTrials.gov Identifier: NCT00518518     History of Changes
Other Study ID Numbers: RNN-3-06-KE
Study First Received: August 17, 2007
Last Updated: May 14, 2009
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
Asthma
Sublingual immunotherapy
Children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013